Within the last few months, China has been formally rolling out their new CFDA regulations that have given startups and new technology developers in China all sorts of benefits. These benefits include allowing the submission of data from clinical trial sites outside of China, allowing more Chinese hospitals to run trials, and allowing drug makers who are waiting for the green light on a safety study to go ahead if they haven’t heard back from the CFDA within 60 days.

All these regulation changes have seen a big boom to China’s biotech innovations. In fact, many Taiwanese companies have seen this regulatory shift as an opportunity to get into the Chinese market. Companies such as Taiwan Liposome (TLC) have started joint ventures with Chinese investors in order to run trials and commercialize their products in China. With the ability to submit their clinical trial data from Taiwan and start their new trials more quickly in China, many of these companies expect to see NDA filings for their assets by the end of the year.

Another highlight of this new regulatory system is that CRISPR human trials have already started within Chinese hospitals. CRISPR in the US, on the other hand, has yet to receive any approval or the go ahead for such trials. Some describe this discrepancy as being the result of China’s lack of regulations. However, that is not necessarily the case. China’s new regulations are geared towards pushing new innovative technologies into trials and out onto market as quickly as possible and has the benefit of being a newly reformed system. In contrast, the US FDA is a much older system using regulations that have been built upon for years, resulting in a much slower and more meticulous process.

Therefore, it might be an advantageous for startups to consider working with Chinese investors through joint ventures. The benefits of having an accelerated clinical trial process with reduced trial costs may be worth the pain of forming a joint venture with a qualified Chinese partner. Of course, while the process of finding a qualified Chinese partner and working with them may be tedious on its own, it definitely should not be immediately discounted. Given how the times are changing, a global outlook towards potential partners and opportunities is becoming more and more necessary in order to succeed.

Hot Mandates

The firm is focused on therapeutics companies and does not invest in medical devices, diagnostics, or digital health. The firm is open to considering assets of very early stages, even those as early as lead optimization phase. The firm considers various modalities, including antibodies, small molecules, and cell therapy. Currently, the firm is not interested in gene therapy. Indication-wise, the firm is most interested in oncology and autoimmune diseases but has recently looked at fibrotic diseases and certain rare diseases as well.

The firm is opportunistic across all subsectors of healthcare. Within MedTech, the firm is most interested in medical devices, artificial intelligence, robotics, and mobile health. The firm is seeking post-prototype innovations that are FDA cleared or are close to receiving clearance. Within therapeutics, the firm is interested in therapeutics for large disease markets such as oncology, neurology, and metabolic diseases. The firm is open to all modalities with a special interest in immunotherapy and cell therapy.

A strategic investment firm of a large global pharmaceutical makes investments ranging from $5 million to $30 million, acting either as a sole investor or within a syndicate. The firm is open to considering therapeutic opportunities globally, but only if the company is pursuing a market opportunity in the USA and is in dialogue with the US FDA.

The firm is currently looking for new investment opportunities in enterprise software, medical devices, and the healthcare IT space. The firm will invest in 510k devices and healthcare IT companies, and it is very opportunistic in terms of indications. In the past, the firm was active in medical device companies developing dental devices, endovascular innovation devices, and women’s health devices.

A venture capital firm founded in 2005 has multiple offices throughout Asia, New York, and San Diego. The firm has closed its fifth fund in 2017 and is currently raising a sixth fund, which the firm is targeting to be the largest fund to date. The firm continues to actively seek investment opportunities across a […]

Featured: All About Innovation Challenge

Companies from all categories of life science are encouraged to apply to Innovation Challenge for RESI Healthtech Week. Eligible companies can apply to Day 1 the First Coast Innovator’s Gathering, Day 2 RESI Global Partnering or both. Applicants will have the opportunity for excellent visibility among investors and strategic partners.

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By James Huang, Research Analyst, LSN We are excited to showcase the top RESI Innovation Challenge startup applicants, who will be taking part in the poster presentation showcase at the second annual RESI BIO held in Boston this year, alongside the BIO International conference. These handpicked companies represent the key sectors of the healthcare space […]

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